Researchers are constantly looking for better ways of treating illness and disease, but their discoveries cannot be put into general use until controlled testing has been done. Clinical trials are the only way that testing can be done. The Food and Drug Administration (FDA) requires clinical trials before it can approve a new treatment as safe and effective for public use.
Pharmaceutical companies, research institutions, or other health organizations may be the sponsor of a clinical trial. The sponsor is responsible for funding and for designing the protocol. A protocol is a set of detailed guidelines that clinical investigators follow in order to conduct the same trial at several different locations. However, only trained doctors, nurses, and medical researchers actually conduct the trial itself.
As a patient under a doctor's supervision, you are protected by the same laws and ethics that normally regulate the medical profession. Informed consent helps protect you by making sure you have been given all the necessary information about a trial. The FDA requires an Institutional Review Board (IRB) to review the general process of the trial. The IRB essentially acts as an ethics committee. As part of this role, the IRB regulates clinical trial advertisements to avoid misleading claims. Progress reports on clinical trials must be submitted at least annually to the IRB.
Pre-clinical testing. A pharmaceutical company conducts laboratory and animal studies to show biological activity of the compound against the targeted disease, and the compound is evaluated for safety. These tests take approximately 6.5 years.
Next, the company files an Investigational New Drug Application (IND) with the FDA to begin the testing in humans. The IND shows (among other things) results of the previous studies; how, where, and by whom the new studies will be conducted; any toxic effects found in the animal studies; and how it is thought to work in the body. The IND must be reviewed and approved by the FDA.